Cleared Traditional

K090440 - HINGE PEDIATRIC PLATING SYSTEM

K090440 is an FDA 510(k) clearance for HINGE PEDIATRIC PLATING SYSTEM, manufactured by Pega Medical, Inc.. The device is a Class 2 Orthopedic device with product code HRS cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K090440 · Pega Medical, Inc. · Orthopedic device
Download Printable Device Report (PDF)
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May 2009
Decision
89d
Days
Class 2
Risk

K090440 is an FDA 510(k) clearance for the HINGE PEDIATRIC PLATING SYSTEM. Classified as Plate, Fixation, Bone within the HRS classification (a category comprising bone fixation plates and orthopedic hardware), Class II - Special Controls.

Submitted by Pega Medical, Inc. (Laval, Quebec, CA). The FDA issued a Cleared decision on May 20, 2009 after a review of 89 days - a notably fast clearance cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.3030 - the FDA orthopedic device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pega Medical, Inc. devices

FDA 510(k) Submission Details - K090440

510(k) Number K090440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2009
Decision Date May 20, 2009
Days to Decision 89 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 122d · This submission: 89d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRS Device Classification - Class 2, Special Controls

Product Code HRS Plate, Fixation, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.3030
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Orthopedic devices follow this clearance model.

Regulatory Peers - HRS Plate, Fixation, Bone

All 1006
Devices cleared under the same product code (HRS) and FDA review panel - the closest regulatory comparables to K090440.
ORTHOLOC ANKLE PLATING SYSTEM (APS)
K091243 · Wrightmedicaltechnologyinc · Jun 2009
CLAVICLE PLATING SYSTEM
K090289 · Orthohelix Surgical Designs, Inc. · Jun 2009
SMITH & NEPHEW, INC. VLP FOOT PLATING, SCREW SYSTEM AND ACCESSORIES
K090675 · Smith & Nephew, Inc. · Jun 2009
ORTHOLOC 2.0/2.4 PLATE SYSTEM
K090692 · Wrightmedicaltechnologyinc · May 2009
PEDIPLATES
K090666 · OrthoPediatrics Corp. · Apr 2009
APTUS 2.0 RADIAL HEAD SYSTEM
K090053 · Medartis AG · Apr 2009